Kornimate/medical-research-clean huggingface dataset:
evaluation of the applicability of personalized tools about nutrition education for malnourished older people

Conditions: Malnutrition of Mild Degree

Summary: describe the frequency of use of nutrition education tools for undernourished older people

the description of the population will identify the characteristics of patients who use the tools and guide their use in patient care. to realize an impact assessment, it necessary to identify specific criteria for inclusion. it is important initially to assess the use of the nutritional tools. the assessment of performance (obstacles and understanding), will be used to improve tools to optimize their use.

Eligibility criteria:
inclusion criteria: * subject of 75 years or more. * hospitalized geriatric day hospital. * living at home, within a radius of 40 km around the hospital xavier arnozan. * subject or caregiver (s) read, understand and speak the french. * undernutrition (criteria of the french high authority for health (has) 2007) * agreed to participate in the study: compendium of the opposition exclusion criteria: * subject not wishing to participate in the study, * mmse (mini mental state examination) \< 20, without presence of a caregiver with no cognitive problems scoring. * identified palliative care. * presenting a contraindication to oral feeding. * presence of supply of enteral or parenteral. * presence with a diagnosis of severe psychiatric pathology. * already participating in a study on undernutrition. * one against medical advice.
ketogenic therapy effects on electrical and metabolic abnormalities in epilepsy

Conditions: Seizures

Summary: approximately a fourth of children with seizures do not respond adequately to available therapy. ketogenic therapy has a long history as treatment for intractable epilepsy, but there is no agreement concerning how it works and what is the best way to administer it. this natural history study will collect data pertaining to both questions.

the basis of ketogenic therapy is an altered macronutrient intake. it is based on a ratio of fat: protein+carbohydrate in which protein intake is adequate and carbohydrate is minimal. on ketogenic therapy, the body metabolizes fat, producing ketones as an energy source for the brain. induction of ketosis has been shown to correlate with the reduction of seizures observed with ketogenic therapy. a major challenge of ketogenic therapy in children is that the compounds provided to stop seizure activity are the same compounds provided for growth and development. the altered macronutrient ratio that is the basis of ketogenic therapy is also a potential risk factor for dyslipidemia and may adversely affect growth. the investigators will evaluate efficacy of ketogenic therapy by assessing seizures and requirements for antiepileptic drugs. the investigators will evaluate adverse effects of ketogenic therapy by assessing dyslipidemia and growth. the investigators will foster optimal daily administration of therapy with structured training programs for caregivers.

Eligibility criteria:
inclusion criteria: * patients whose physician has prescribed the ketogenic diet * patients with lab tests consistent with the ability to metabolize a high fat and low carbohydrate diet * patients that can be compliant with administration of the therapy and with record keeping. exclusion criteria: * patients with lab tests consistent with the inability to metabolize a high fat and low carbohydrate diet * patients at risk of being non-compliant with administration of the therapy and with record keeping

Keywords: ketogenic therapy ketogenic diet
two-dose schedule of quadrivalent hpv recombinant vaccine in 11-year-old boys in mexico city

Conditions: Human Papilloma Virus

Summary: in the genital tract human papilloma virus (hpv), especially types 6 and 11 cause genital warts, the commonest viral sexually transmitted disease. the hpv 16 and 18 are the most common oncogenic "high-risk" genotypes and cause approximately 70% of all cervical cancers despite the fact that are associated with other anogenital cancers, anus, vagina, vulva and penis, and cancers of the head and neck. current estimates are that 5.2% of all cancers are hpv associated. a large number of studies, including both adult and young females, have demonstrated that hpv vaccines are highly immunogenic and induce a long lasting protection against infection. immunogenic vaccination results in young men and boys are equally satisfactory with the quadrivalent hpv (types 6, 11, 16, 18) vaccine recommended for men. the recommended vaccination scheme includes three shots giving the second at two months and the third at six months after the initial shot. recently, it has been shown that the use of a two shot scheme (0 and 6 months) is equally effective among girls. the purpose of this study is to determine that the immunogenicity is non-inferior in boys using a two shot scheme compared with young women and girls.


Eligibility criteria:
inclusion criteria: * all those children whose parents accept their participation in the study. exclusion criteria: * fever, * previous vaccination against hpv, * allergy to vaccine components, * thrombocytopenia, * immunosuppression, * diarrhea, * vomiting, * dyscrasia, * administration of another anti-viral vaccine in the previous 15 days.

Keywords: quadrivalent vaccine
effect of antidepressants on back pain

Conditions: Back Pain; Sciatica

Summary: the purpose of this study is to determine whether different types of antidepressant medicines relieve back pain that has lasted at least six months on a daily basis. study participants will be assigned to treatment with either a antidepressant acting on the serotonin system in the brain (fluoxetine), one acting on the noradrenaline system (desipramine, or to a control medication not expected to relieve pain (benztropine). each participant will be seen at least nine times during their 12 weeks on medication. this is a phase 2/3, outpatient study.


Eligibility criteria:
inclusion criteria: * chronic back pain (pain on a daily basis for six months or longer) * age 18-65 * no major medical illness exclusion criteria: * medical contraindication to tricyclic antidepressants * recent alcohol or substance use disorder * bipolar disorder

Keywords: analgesia back pain sciatica
the application of a mask in patients with severe covid-19 already treated with high-flow nasal cannula.

Conditions: Covid19

Summary: patients with severe hypoxemic respiratory failure due to covid-19 are often treated with oxygen delivered through a high-flow nasal cannula (hfnc). this is according to guidelines. we have made the clinical observation that oxygenation sometimes improves when a mask (e.g. oxygen mask or inhalation mask) is applied on top of the hfnc. this has quickly become a clinical routine at intermediary care units at our hospital, where patients with hfnc are offered to test the intervention (mask + hfnc) as part of clinical routine. this study aims to evaluate this new routine in a standardised way.

patients with severe covid-19, treated with hfnc, will be approached for consent. if inclusion critera and no exclusion criteria are fulfilled, baseline measurements will be taken without mask, including arterial blood gas analysis (abg) then a simple oxygen mask will be applied covering nose and mouth, without providing supplemental oxygen. after 30 minutes with mask + hfnc, new measurements will be taken, including abg. after 30 minutes, the mask is removed and when steady state occurs, new measurements will be taken, without abg. then, the patients could continue using the mask as part of clinical routine

Eligibility criteria:
inclusion criteria: * verified covid19 infection * treatment with hfnc * estimated p/f ratio of ≤ 13 kpa exclusion criteria: * language barrier * unable to provide consent * risk of deterioration due to study

Keywords: critical care non-invasive ventilation
study of hypotensive hematopoietic malignancy patients' uscom readings

Conditions: Leukemia; Lymphoma; Paraproteinemias; Multiple Myeloma; Myelodysplastic Syndromes

Summary: the purpose of this study is to test how practical it is to use the ultrasonic cardiac output monitor (uscom), an fda-approved device, on oncology patients (specifically those with blood cancers). additionally, the researchers will learn if the uscom gives additional information about patients' conditions when their blood pressures drop and they are treated with intravenous fluids.


Eligibility criteria:
inclusion criteria: -≥ 18 years of age * english speaker * diagnosis of blood dyscrasia, hematopoietic malignancy, or condition that may requires hsct exclusion criteria: * obstruction of the suprasternal notch that prevents placing the uscom probe in the correct location * tracheostomy or endotracheal tube that prevents placing uscom probe in the correct location * inability to lie flat, on left or right side, or with the head of bed at a 30 degree angle for the uscom exam (ex. due to respiratory distress or physiologic reasons) * impairment by a psychiatric, cognitive, or physiologic disorder that limits ability to understand explanation of study and give consent
the five-repetition sit-to-stand test for lower back pain or radiculopathy

Conditions: Degenerative Disc Disease; Degenerative Spondylolisthesis; Herniated Disc; Stenosis, Spinal; Nerve Root Compress;Lumbosac

Summary: the five-repetition sit-to-stand test (5r-sts) has been used in many medical disciplines, but has never been correlated with or validated in regard to degenerative spinal diseases. the investigators aim to assess the possibility of using the standardized 5r-sts as an objective measure of functional impairment and pain severity in patients with degenerative lumbar spinal diseases.


Eligibility criteria:
this study will include 100 patients: inclusion criteria: * degenerative diseases of the lumbar spine (herniated disc, lumbar stenosis, spondylolisthesis, degenerative disc disease) * symptoms of lower back pain, neurogenic claudication, or radiculopathy exclusion criteria: * hip or knee prosthetics * walking aides this study will also include 25 healthy volunteers: inclusion criteria: - no degenerative spinal or lower extremity complaints exclusion criteria: * back pain, leg pain, other lower extremity-related complaints * knee or hip prosthetics * walking aides
obstructive sleep apnea influences efficacy of pd-1-based immunotherapy against non-small cell lung cancer

Conditions: Obstructive Sleep Apnea; Non-small Cell Lung Cancer

Summary: this prospective, observational cohort study aims to explore the influence of obstructive sleep apnea(osa) on the efficacy of pd-1-based immunotherapy in patients with non-small cell lung cancer(nsclc). patients who had no prior treatment for advanced nsclc and are intended to receive pd-1/pd-l1 antibody will be recruited. according to sleep monitor results, participants will be divided into group nsclc and group osa+nsclc. primary outcome is the objective remission rate(orr).

this is a single-center, prospective, observational cohort study. patients who had no prior treatment for advanced nsclc and are intended to receive pd-1/pd-l1 antibody will be recruited and followed for 4 years. according to the baseline sleep monitor results, participants will be divided into group nsclc(ahi\<15), and group osa+nsclc(ahi≥15), and then explore the influence of obstructive sleep apnea on the efficacy of pd-1-based immunotherapy. the baseline level of white blood cell count (wbc); absolute neutrophil count (anc); absolute lymphocyte count (alc); anc to alc (anc:alc) ratio; interleukin 6 (il-6); c-reactive protein (crp) in peripheral blood, lymphocytes classification and count by flow cytometry, and gut microbiome analysis by quantitative metagenomics will also be measured to further search for the possible mechanisms. primary outcome is the objective remission rate (orr), secondary outcomes include overall survival (os) and progression free survival (pfs). the study protocol has been approved by the peking university first hospital institutional review board (irb). any protocol modifications will be submitted for the irb review and approval.

Eligibility criteria:
inclusion criteria: 1. histologically or cytologically confirmed, advanced nsclc 2. participants with no prior treatment for advanced nsclc 3. measurable disease as defined by recist v1.1 4. eligible to receive first-line treatment including pd-1 antibody 5. adequate hematologic and end organ function exclusion criteria: 1. severe infection within 4 weeks prior to recruitment. 2. significant organ dysfunction or other serious diseases. 3. previous or current osa related treatment, including oral appliance, surgery, mechanical ventilation therapy. 4. illness or condition that interferes with the participant's capacity to understand, follow and/or comply with study procedures.
skin adverse reactions occuring in children treated by biotherapy for chronic inflammatory disease

Conditions: Biotherapy; Chronic Inflammatory Disease; Allergic Skin Reaction; Pediatric Disorder; Dermatologic Complication; Gastrointestinal Disease; Ophthalmology; Rheumatology

Summary: biological treatments (bt) are commonly prescribed to treat chronic inflammatory diseases in children. paradoxical reactions during treatment with a biological agent can be defined as the appearance or exacerbation of a pathological condition that usually responds to this class of drug while treating a patient for another condition. limited data are available in children treated by bt on cutaneous paradoxical reactions, or any other cutaneous adverse events occurring during treatment. on the contrary, dermatologists tend to see and manage increasing numbers of cutaneous adverse events, including paradoxical reactions. the aim of this project is to describe the incidence of cutaneous adverse events, including cutaneous paradoxical reactions, occurring in the pediatric population, during a treatment by bt given for a chronic inflammatory disease.


Eligibility criteria:
inclusion criteria: * children under 18 years old * children treated by biotherapy among : adalimumab, golimumab, infliximab, ustekinumab, etanercept, tocilizumab, canakinumab, anakinra, abatacept. * children treated for a chronic inflammatory disease (rheumatologic, gastro-enterologic, dermatologic and ophthalmologic) * children treated in the chu of amiens * parental consent signed exclusion criteria: * age \> 18 ans

Keywords: biotherapy chronic inflammatory disease skin adverse event paradoxical reaction cutaneous manifestation pediatry dermatology gastro-enterology ophthalmology rheumatology
safety and tolerability of e5555 and its effects on markers of intravascular inflammation in subjects with coronary artery disease

Conditions: Coronary Artery Disease

Summary: the primary purpose of this study is to assess the safety and tolerability of e5555 in subjects with coronary artery disease.

this was a multicenter, randomized, double-blind, placebo-controlled trial of e5555, a par-1 inhibitor. the total duration of individual study participation was 28 weeks (196 days). this included a treatment period of 24 weeks (168 days) and a follow-up period of 4 weeks (28 days).

Eligibility criteria:
inclusion criteria: 1. males or females, 45 - 80 years of age 2. confirmed coronary artery disease defined as one of the following: * post-acute coronary syndrome or myocardial infarction or * post percutaneous coronary intervention or coronary artery bypass graft or oangina pectoris with documented (electrocardiogram or imaging study) ischemia or * angiographically documented lesion occluding ≥70% of a coronary vessel and at high risk as defined as one or more of the following: * elevated hscrp (high-sensitivity c-reactive protein) * diabetes mellitus * history of carotid artery disease and/or peripheral artery disease * thrombo-embolic transient ischemic attack or stroke \>1 year prior to screening 3. all subjects must be receiving low dose aspirin and/or clopidogrel and/or ticlopidine. exclusion criteria 1. history of acquired or congenital bleeding disorder, coagulopathy or platelet disorder, or history of pathological bleeding within the last 6 months 2. history of intracranial bleeding, history of hemorrhagic retinopathy or known structural cerebral vascular lesion 3. clinically significant hematological, hepatic or renal abnormalities 4. patients with some specific st-segment changes, severe congestive heart failure or uncontrolled cardiac arrhythmias at baseline 5. recent significant (as determined by the investigator) cardiovascular events

Keywords: coronary artery disease
pk study with pantoprazole in obese children and adolescents

Conditions: Gastroesophageal Reflux Disease

Summary: multicenter, comparative single-dose pharmacokinetic (pk) study

evaluate the pharmacokinetics of pantoprazole in obese children and adolescents with gastroesophageal reflux disease (gerd) following administration of an oral dose of pantoprazole.

Eligibility criteria:
inclusion criteria: 1. participant is between 6 and 17 (inclusive) years of age at the time of consent 2. bmi ≥95th percentile 3. diagnosis of gerd established prior to 7 days before receipt of study drug dose defined as 1 or more of the following: 1. clinical symptoms consistent with gerd as determined by the investigator 2. a diagnosis of erosive esophagitis by endoscopy 3. esophageal biopsy with histopathology consistent with reflux esophagitis 4. abnormal ph-metry consistent with reflux esophagitis 5. other test result consistent with gerd 4. written informed consent from the parent or legally authorized representative/guardian and participant assent per local irb recommendation of age-appropriate consent and assent requirements exclusion criteria: 1. use of pantoprazole, lansoprazole, omeprazole, esomeprazole or rabeprazole within 48 hours prior to dose of study drug 2. use of fluoxetine, fluvoxamine, ketoconazole, ticlopidine, felbamate, topiramate, valproic acid, phenobarbital, carbamazepine, erythromycin, clarithromycin, grapefruit juice, verapamil, diltiazem, cimetidine, st. john's wort, rifampin, rifapentine within seven days prior to dose of study drug 3. consumption of food after midnight on the day of the baseline visit 4. symptomatic asthma 5. type i diabetes 6. history of adverse reaction to ppi 7. impaired hepatic activity as defined as any of the following: ast ≥150 iu/l, alt ≥150 iu/l, total bilirubin ≥2.0 mg/dl, or alkaline phosphatase ≥600 iu/l 8. serum creatinine ≥2.0 mg/dl 9. for females of childbearing potential, a positive pregnancy test result 10. known infection with hepatitis b, c, or hiv 11. any other condition that, in the opinion of the principal investigator, makes participation unadvised or unsafe.

Keywords: obese children adolescents gerd pharmacokinetic
a study using micronised progesterone (crinone® 8%) in the luteal phase support of women undergoing in vitro fertilisation (ivf) and embryo transfer (et)

Conditions: Infertility

Summary: this was an open-label, randomized, comparative, phase iii study to evaluate the safety and efficacy of crinone 8% in comparison with progesterone 60 mg intramuscular (i.m.) administered once a day in luteal phase support in 200 chinese female subjects undergoing ivf/et.

this was an open-label, randomized, comparative, multicentric, phase iii study to evaluate the safety and efficacy of crinone 8% in comparison with progesterone 60 mg intramuscular administered once a day in luteal phase support in chinese female subjects undergoing ivf/et. the study planned to enroll 200 female subjects who underwent pituitary down-regulation as per each center's normal practice prior to and during stimulation of multiple follicular development. the progesterone administration was started on the day of et. randomisation was performed on the day of et. if pregnancy was confirmed on day 14 of the progesterone administration, the progesterone was continued for another 45 days. the subjects were followed up and the treatment outcome (negative pregnancy test or pregnancy) was recorded.

Eligibility criteria:
inclusion criteria: * patient has given written informed consent * bmi \< 25 kg/m2 * age \< 36 years * \<3 prior art cycles (ivf, icsi and related procedures) * infertility * regular spontaneous ovulatory menstrual cycles exclusion criteria: * habitual abortion * hydrosalpinges * history of past poor response to coh * patients with serious arterial, lung, hepatic and renal diseases * hepatic and renal impairment

Keywords: fertilisation, in vitro embryo transfer progesterone reproductive technologies, assisted
endurant chevar new indication trial: enchant

Conditions: AAA - Abdominal Aortic Aneurysm

Summary: the purpose of the post-market study is to assess the clinical outcomes, safety, and performance of the endurant chimney graft technique (endurant stent graft systems used with a balloon-expandable covered stent graft) for treatment of juxtarenal aortic aneurysms with a short infrarenal neck in a real world setting.


Eligibility criteria:
inclusion criteria: * subject is ≥18 years old * subject is scheduled for primary treatment of the juxtarenal aortic aneurysm with a short infrarenal neck (i.e. no revision subjects) * subject is able and willing to comply with the protocol and to adhere to the follow-up requirements * subject has provided written informed consent * subject is an eligible candidate according to the currently available endurant ii/iis instructions for use for chevar * subject has a juxtarenal aortic aneurysm with a short infrarenal neck (definition of juxtarenal aortic aneurysm with a short infrarenal neck will be in accordance with commercially available endurant ii/iis instructions for use for chevar). exclusion criteria: * subject is participating in a concurrent study which may confound study results * subject has a life expectancy ≤ 2 year * subject has an aneurysm that is: * suprarenal or pararenal * isolated iliofemoral * mycotic * inflammatory * pseudoaneurysm * subject requires emergent aneurysm treatment, for example, trauma or rupture * subject has previously undergone surgical treatment for abdominal aortic aneurysm * subject is a female of childbearing potential in whom pregnancy cannot be excluded * subject has a known hypersensitivity or contraindication to anticoagulants, anti-platelets, or contrast media, which is not amenable to pre-treatment * subject has a creatinine level \>2.0 mg/dl (or \>176.8 μmol/l) and/or is on dialysis * subject has an active covid-19 infection or relevant history of covid-19. relevant history of covid-19 is defined as availability of a positive covid-19 test with sequela or hospitalization for treatment of covid-19. subjects with a positive covid-19 test who were asymptomatic or had mild symptoms should be excluded only if the positive test was less than 6 months prior to enrollment

Keywords: chevar chimney juxtarenal short infrarenal /neck endurant
integrated navigation services for treatment adherence, counseling, and research

Conditions: HIV Infection Primary

Summary: the goal of this research is to determine whether a community health worker (chw) intervention including a mobile telehealth (m-health) component can help achieve long term viral suppression among black people with poorly controlled hiv.


Eligibility criteria:
inclusion criteria: * ages 18 years or older * patient from adult hiv outpatient clinic at university of miami/jackson memorial health system * self-identify as black * uncontrolled viral suppression as determined by treating clinician * english speaking exclusion criteria: * any other condition(s) that the treating clinician determines would limit participant from meaningful study participation.

Keywords: hiv viral suppression community health worker